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Anti-Endomysium Antibodies (aea)

EUDAMED

Class IVD General (EU MDR)

Ref 44548Ref 44715Ref 50057Ref 44148Ref 44710

by Biosystems S.a.

Identity

Device Name
ANTI-ENDOMYSIUM ANTIBODIES (AEA) EUDAMED
Model / Reference
44548 EUDAMED
44715 EUDAMED
50057 EUDAMED
44148 EUDAMED
44710 EUDAMED

Identifiers

Primary DI / UDI-DI
08435287145489 EUDAMED
08435287147155 EUDAMED
08012992500576 EUDAMED
08435287141481 EUDAMED
08435287147100 EUDAMED
Basic UDI-DI
B-08435287145489 EUDAMED
B-08435287147155 EUDAMED
B-08012992500576 EUDAMED
B-08435287141481 EUDAMED
B-08435287147100 EUDAMED
EMDN Code
W0102100603 ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Anti-Endomysium Antibodies (aea) by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Biosystems S.a.
EUDAMED SRN
ES-MF-000000231

Sources (5)

  • EUDAMED 8c08109a-e81e-4ed5-9f8e-2120d29ac415 61 fields · synced Sep 17, 2026
  • EUDAMED 3ea62e3d-c29b-420b-956b-c479eeba9384 61 fields · synced May 17, 2026
  • EUDAMED d81c9889-b3ca-4e14-8a39-f862762fc78a 61 fields · synced May 17, 2026
  • EUDAMED 352f4552-487f-4a96-abf7-c7fe4fd7273f 61 fields · synced May 18, 2026
  • EUDAMED e3037594-dcdc-4b16-9e0e-0430f9b7e231 61 fields · synced May 19, 2026